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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

This study is currently recruiting participants.
Verified September 2016 by Stemcentrx
Sponsor:
ClinicalTrials.gov Identifier:
NCT02709889
First Posted: March 16, 2016
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stemcentrx
  Purpose
To assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

Condition Intervention Phase
Malignant Melanoma Medullary Thyroid Cancer Glioblastoma Large Cell Neuroendocrine Carcinoma Neuroendocrine Prostate Cancer High Grade Gastroenteropancreatic Neuroendocrine Carcinoma Other Neuroendocrine Carcinoma Other Solid Tumors Drug: Rovalpituzumab tesirine Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Stemcentrx:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 1 year ]
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
  • Duration of response [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
  • Progression free survival [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
  • Overall survival [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
  • Clinical benefit rate [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
  • Maximum Plasma Concentration (Cmax) [ Time Frame: Cycles 1, 2 and 4: day 1 (pre-dose, 30 min post-dose, 6 hours post-dose), 3, 8, 15, 29; Cycles 3, 5 and above: day 1, 8, 15, 29; up to 1 year. ]
  • Area Under the Curve (AUC) [ Time Frame: Cycles 1, 2 and 4: day 1 (pre-dose, 30 min post-dose, 6 hours post-dose), 3, 8, 15, 29; Cycles 3, 5 and above: day 1, 8, 15, 29; up to 1 year. ]
  • Anti-therapeutic Antibodies (ATA) [ Time Frame: Cycles 1, 2 and 4: day 1 (pre-dose, 30 min post-dose, 6 hours post-dose), 3, 8, 15, 29; Cycles 3, 5 and above: day 1, 8, 15, 29; up to 1 year. ]

Estimated Enrollment: 378
Study Start Date: September 2016
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rovalpituzumab tesirine
Rovalpituzumab tesirine 0.2-0.4 mg/kg will be administered intravenously on Day 1 of each 6-week cycle.
Drug: Rovalpituzumab tesirine
Other Name: SC16LD6.5

Detailed Description:
This is a multicenter, open-label study involving multiple specific advanced solid tumor types, consisting of a dose escalation Part A followed by an expansion Part B. Cancer subtypes will be studied in separate disease-specific cohorts in both Parts. Eight separate cohorts will enroll malignant melanoma, medullary thyroid cancer (MTC), glioblastoma, large cell neuroendocrine carcinoma (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic (GEP), neuroendocrine carcinoma (NEC), other NEC, and solid tumors other than the above.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
  • Measurable disease as defined by RECIST 1.1
  • DLL3-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Minimum life expectancy of at least 12 weeks
  • Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only)
  • Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration
  • Adequate hematologic and organ function as confirmed by laboratory values
  • Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:

    1. Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
    2. Immune-checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression).
  • Females of childbearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.

Exclusion Criteria:

  • Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
  • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV (see Appendix 12.4) within 6 months prior to their first dose of study drug.
  • Recent or ongoing serious infection, including:

    1. Any active grade 3 or higher (per NCI CTCAE version 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
    2. Known seropositivity for or active infection by human immunodeficiency virus (HIV).
    3. Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.
  • Women who are pregnant or breastfeeding
  • Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
  • History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear.
  • Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709889


Contacts
Contact: SCRX001-006 Study Team scrx001-006@stemcentrx.com

  Show 26 Study Locations
Sponsors and Collaborators
Stemcentrx
Investigators
Study Director: Edward Kavalerchik, MD Stemcentrx
  More Information

Responsible Party: Stemcentrx
ClinicalTrials.gov Identifier: NCT02709889     History of Changes
Other Study ID Numbers: SCRX001-006
First Submitted: March 2, 2016
First Posted: March 16, 2016
Last Update Posted: August 22, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma
Glioblastoma
Thyroid Neoplasms
Melanoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Neuroendocrine Tumors
Nevi and Melanomas
Adenocarcinoma


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